Clinical Research Associate II (Sponsor-dedicated)
Descripción del trabajo
IQVIA is a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
For our Sponsor-dedicated Clinical Monitoring department in Estonia we are currently looking to further strengthen our team with a Clinical Research Associate 2 to join us on a permanent contract and support us, our clients and local patients in developing new drugs and new indications across a plethora of therapeutic areas.
The compensation package includes a competitive salary, car allowance/company car , performance-based bonus, IT equipment and several benefits (i.e. accident insurance, compensation for glasses, sport card and vacation bonus)
Essential Functions of a Clinical Research Associate II
·Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
·Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
·Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
·Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
·Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
·Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
·Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
·Collaborate and liaise with study team members for project execution support as appropriate.
·Bachelor's Degree or Master's Degree, ideally in scientific discipline or healthcare
·Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
·Minimum 1 year of independent on site monitoring experience
·Written and verbal communication skills including good command of English and Estonian
Why should you apply?
·You'd join a global team of 70.000+ brave minds
·In 2020 we completed almost 4.000 recruitment processes internally; once you join us, not even the sky is the limit
·We've been nominated a top 500 company every year since our inception in 2016
·FLEXJOBS awarded us the 9th spot in the top 100 Companies for Remote Jobs in 2021
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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